(194 days)
Not Found
No
The summary describes a collagen matrix wound dressing and its physical properties and performance compared to predicate devices. There is no mention of AI or ML technology.
Yes
Explanation: The device is indicated for the local management of various types of wounds, including chronic ulcers and surgical wounds, which are conditions that require therapeutic intervention for healing.
No
This device is a wound dressing designed for the local management of various types of exuding wounds. Its intended use is therapeutic, facilitating wound healing, rather than diagnostic, which would involve identifying a disease or condition. The performance studies focus on physical attributes and comparative strength, not diagnostic accuracy.
No
The device description clearly states it is a "decellularized equine pericardial device" and describes its physical form (dressing, available in sizes, fenestrated model). This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "local management of moderately to heavy exuding wounds." This describes a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical wound dressing made from decellularized equine pericardium. This is a material applied directly to a wound, not a reagent or instrument used to test samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis.
- Performance Studies: The performance studies focus on physical properties like tensile strength and suture pull-out, and biocompatibility. These are relevant to a wound dressing's function and safety, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- Draining wounds, .
- Pressure sores/ulcers. .
- Venous ulcers, ●
- Chronic vascular ulcers, .
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
The Harbor MedTech BriDGE Extracellular Collagen Matrix (ECM) Wound Dressing is a decellularized equine pericardial device that has been stabilized and radiation sterilized. The BriDGE ECM is non-pyrogenic and is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.
The BriDGE ECM is available in four sizes. The BriDGE ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix. A table of proposed model numbers and sizes is provided below:
| Model Number | Dimensions | Description |
|---|---|---|
| HMT009 | 3 cm x 3 cm | Standard |
| HMT036 | 6 cm x 6 cm | Standard |
| HMT100 | 10 cm x 10 cm | Standard |
| HMT150 | 10 cm x 15 cm | Standard |
| HMT009F | 3 cm x 3 cm | Fenestrated |
| HMT036F | 6 cm x 6 cm | Fenestrated |
| HMT100F | 10 cm x 10 cm | Fenestrated |
| HMT150F | 10 cm x 15 cm | Fenestrated |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical studies were conducted to assess the physical attributes of the collagen biomaterial and manufacturing processing. Complete biocompatibility studies were conducted on the material. Results of all performance tests were found to be acceptable. Biocompatibility testing was performed under Good Laboratory Practices (GLP) by NAmSA in accordance with the relevant parts of ISO 10993 Biological Evaluation of Medical Devices. All GLP testing met the criteria for biocompatibility. The testing criteria followed were based on the following medical device categorization: surface device, breached or compromised surface, prolonged contact (>24h to ≤30 days).
A study was conducted to compare the ultimate tensile strength of the BriDGE ECM to the predicate devices: Unite Biomatrix and Oasis Wound Matrix. Samples were rehydrated and pull tested for peak load (N). The tensile strength of the BriDGE ECM was equivalent to the Unite Biomatrix and significantly stronger than the Oasis Wound Matrix samples.
A study was conducted to determine the functional tensile strength characteristics of the fenestrated version of the BriDGE Extracellular Collagen Matrix. Samples were rehydrated and pull tested for peak load (N). The results were compared to the tensile strength data collected for the standard BriDGE Extracellular Collagen Matrix (non-fenestrated). The samples were pulled both vertically and horizontally. The results of the testing showed that the fenestrated BriDGE ECM samples were comparable to the non-fenestrated BriDGE ECM samples and stronger than the Oasis Wound Matrix non-fenestrated samples.
The BriDGE ECM was tested to characterize the device in terms of suture pull out resistance. The samples were hydrated and a 4-0 Prolene suture was attached and pull tested for peak load (N). Comparison testing was performed using samples of the predicate devices: Unite Biomatrix and Oasis Wound Dressing. The BriDGE ECM was found to be equivalent to the predicate devices in terms of suture pull-out strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
FEB 2 6 2013
510(k) SUMMARY K122502 Harbor MedTech, Inc. BriDGE Extracellular Collagen Matrix Wound Dressing
ADMINISTRATIVE INFORMATION:
Manufacturer Name:
Harbor MedTech, Inc. 4 Jenner, Suite 190 Irvine, CA 92618 (949) 679-4800 Telephone: Facsimile: (949) 679-1086 Email: jerrym@harbormedtech.com
Official Correspondent:
Jerry Mezger, Chief Executive Officer
Additional Correspondent:
Carol White, QA/RA Consultant 21521 Hummingbird Street Trabuco Canyon, CA 92679 (949) 874-2024 Telephone: Facsimile: (949) 589-0442 Email: carolwhite@cox.net
DEVICE NAME AND CLASSIFICATION
BriDGE Extracellular Collagen Matrix Wound Dressing Trade/Proprietary Name: Common Name: Dressing, Wound, Collagen Classification Regulation: Unclassified Product Code: KGN Device Class: Unclassified Review Panel: General & Plastic Surgery
INTENDED USE
The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- Draining wounds, .
- Pressure sores/ulcers. .
- Venous ulcers, ●
- Chronic vascular ulcers, .
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears),
1
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)
DEVICE DESCRIPTION
The Harbor MedTech BriDGE Extracellular Collagen Matrix (ECM) Wound Dressing is a decellularized equine pericardial device that has been stabilized and radiation sterilized. The BriDGE ECM is non-pyrogenic and is provided sterile for single use only. The device must be rehydrated and rinsed prior to use following the procedure described in the Instructions for Use.
The BriDGE ECM is available in four sizes. The BriDGE ECM is available as a standard dressing and in a fenestrated model with pre-cut slits in the collagen matrix. A table of proposed model numbers and sizes is provided below:
| Model Number | Dimensions | Description |
|---|---|---|
| HMT009 | 3 cm x 3 cm | Standard |
| HMT036 | 6 cm x 6 cm | Standard |
| HMT100 | 10 cm x 10 cm | Standard |
| HMT150 | 10 cm x 15 cm | Standard |
| HMT009F | 3 cm x 3 cm | Fenestrated |
| HMT036F | 6 cm x 6 cm | Fenestrated |
| HMT100F | 10 cm x 10 cm | Fenestrated |
| HMT150F | 10 cm x 15 cm | Fenestrated |
EQUIVALENCE TO MARKETED PRODUCT
Harbor MedTech, Inc., demonstrated that, for purposes of FDA's regulation of medical devices, the BriDGE Extracellular Collagen matrix (ECM) Wound Dressing is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
The Harbor MedTech BriDGE ECM Wound Dressing is substantially equivalent to the following predicate devices: Pegasus Biologics Inc., Unite™ Biomatrix Collagen Wound Dressing K071425, and Cook Biotech, Inc., Oasis Wound Dressing K061711.
The BriDGE Extracellular Collagen Matrix Wound Dressing has the same intended use as the predicate devices and incorporates the same basic design. The proposed device and the predicate devices are available as sheets in multiple sizes and are either sold pre-fenestrated (Pegasus) or may be fenestrated by the physician (Oasis). The BriDGE ECM undergoes a lyophilization process during manufacturing as does the Oasis predicate device. Device stabilization of the BriDGE ECM is achieved by using BDDGE, whereas the Pegasus predicate device uses EDC and the Oasis predicate device process is unknown. The BriDGE ECM and the Pegasus predicate device utilize equine pericardium and the Oasis predicate device utilizes porcine SIS.
2
PERFORMANCE TESTING
A number of preclinical studies were conducted to assess the physical attributes of the collagen biomaterial and manufacturing processing. Complete biocompatibility studies were conducted on the material. Results of all performance tests were found to be acceptable. The BriDGE Extracellular Collagen Matrix Wound Dressing is as safe and as effective as the predicate devices.
Biocompatibility testing was performed under Good Laboratory Practices (GLP) by NAmSA in accordance with the relevant parts of ISO 10993 Biological Evaluation of Medical Devices. All GLP testing met the criteria for biocompatibility. The testing criteria followed were based on the following medical device categorization: surface device, breached or compromised surface, prolonged contact (>24h to ≤30 days).
| Biocompatibility Summary - BriDGE Extracellular Collagen Matrix | ||
|---|---|---|
| Cytotoxicity | ||
| ISO Elution Method | ISO 10993-5 | Pass - non-toxic |
| Genotoxicity | ||
| Mouse Lymphoma Assay | ISO 10993-3 | Pass - non-mutagenic |
| Systemic Toxicity | ||
| ISO Study in Mice | ISO 10993-11 | Pass - non-toxic |
| Intracutaneous | ||
| ISO Study in Rabbits | ISO 10993-10 | Pass - non-irritant |
| Sensitization | ||
| ISO Guinea Pig Maximization | ISO 10993-10 | Pass - non-sensitizing |
| Mouse Peripheral Blood | ||
| Micronucleus Study | OECD Test No. 474 | Pass - no micronuclei in mice |
| Bacterial Reverse Mutation Study | ISO 10993-3 | Pass - non-mutagenic |
| Rabbit Pyrogen | ||
| USP Material Mediated | ISO 10993-11 | Pass - non-pyrogen |
The following table summarizes the material testing performed.
Tensile Strength Testing
A study was conducted to compare the ultimate tensile strength of the BriDGE ECM to the predicate devices: Unite Biomatrix and Oasis Wound Matrix. Samples were rehydrated and pull tested for peak load (N). The tensile strength of the BriDGE ECM was equivalent to the Unite Biomatrix and significantly stronger than the Oasis Wound Matrix samples.
A study was conducted to determine the functional tensile strength characteristics of the fenestrated version of the BriDGE Extracellular Collagen Matrix. Samples were rehydrated and pull tested for peak load (N). The results were compared to the tensile strength data collected for the standard BriDGE Extracellular Collagen Matrix (non-fenestrated). The samples were pulled both vertically and horizontally. The results of the testing showed that the fenestrated
3
BriDGE ECM samples were comparable to the non-fenestrated BriDGE ECM samples and stronger than the Oasis Wound Matrix non-fenestrated samples.
Suture Pull-Out Testing
The BriDGE ECM was tested to characterize the device in terms of suture pull out resistance. The samples were hydrated and a 4-0 Prolene suture was attached and pull tested for peak load (N). Comparison testing was performed using samples of the predicate devices: Unite Biomatrix and Oasis Wound Dressing. The BriDGE ECM was found to be equivalent to the predicate devices in terms of suture pull-out strength.
Based on the results of the performance bench testing and comparison to predicate devices, Harbor MedTech has demonstrated that the BriDGE Extracellular Collagen Matrix Wound Dressing is equivalent to the predicate devices in terms of performance characteristics and will perform as intended for the application of the product.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Harbor Medtech, Incorporated % Mr. Jerry Mezger Chief Executive Officer 4 Jenner, Suite 190 Irvine, California 92618
February 26, 2013
Re: K122502
Trade/Device Name: Bridge Extracellular Collagen Matrix Regulation Number: Unclassified Regulation Name: Dressing, Wound Collagen Regulatory Class: Unclassified Product Code: KGN Dated: January 29, 2013 Received: February 25, 2013
Dear Mr. Mezger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
5
Page 2 - Mr. Jerry Mezger
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Peter Diffillimm -S
FOR
Mark N. Meikerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Premarket Notification
BriDGE Extracellular Collagen Matrix Wound Dressing
INDICATIONS FOR USE
510(k) Number (if known): K122502
Device Name:
BriDGE Extracellular Collagen Matrix Wound Dressing
Indications for Use:
The Harbor MedTech BriDGE Extracellular Collagen Matrix Wound Dressing is indicated for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- . Draining wounds,
- . Pressure sores/ulcers,
- Venous ulcers, .
- Chronic vascular ulcers, .
- . Diabetic ulcers,
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), .
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric . wounds, dehisced surgical incisions)
X Prescription Use (21 CFR 801 Subpart D)
and/or
Over-the-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang
(Division Sign-Off) Division of Surgical Devices 510(k) Number K122502